Shift Work Type Circadian Rhythm Sleep Disorder Clinical Trial
— SWISHOfficial title:
Developing a Sleep Health Intervention for Shift Workers
The aim of this study is to pilot test a comprehensive, personalized, media-augmented telehealth intervention ("SWISH") designed to improve sleep health among shift workers.
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | March 2027 |
Est. primary completion date | September 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Provision of signed and dated informed consent form - Any gender; Ages 18-65 - Currently employed as a nurse in the state of Oregon - Currently have shift work schedules (i.e., stable night shift or rotating shifts that include nights, >=3 nights/week) and have worked shift work >=3 nights/week for at least 3 months - Expect to have a shift work schedule >=3 nights/week over the next 6 months endorse poor sleep, as evidenced by T-score >=60 on the PROMIS Sleep Disturbance OR Sleep-Related Impairment measure - Have daily access to the internet on a smartphone, table, or computer; and - Can read and write in English. Exclusion Criteria: - Conditions which make study treatment likely to be ineffective. For example, current chronic use of medications that interfere with sleep, alcohol or substance use disorder, or thought disorder (as determined by DIAMOND psychiatric interview), unstable sleep or medical conditions that necessitate additional medical care not provided by study treatments (e.g., known untreated sleep apnea). - Presence of safety risk or condition in which study participation may result in increased risk to safety (e.g., elevated risk for suicide, self-reported uncontrolled seizure disorder, history of manic or hypomanic episode, current pregnancy), - Currently receiving non-pharmacological treatment for insomnia (e.g., cognitive behavioral therapy for insomnia) and/or current unstable hypnotic/alerting medication use OR - Currently participating in other research studies with substantial overlap in terms of methods/procedures (e.g., PI's ongoing study "Piloting an Adaptation of Cognitive Behavioral Therapy for Insomnia for Shift Workers (CBTI-Shift)" |
Country | Name | City | State |
---|---|---|---|
United States | Oregon State University | Corvallis | Oregon |
Lead Sponsor | Collaborator |
---|---|
Oregon State University | National Heart, Lung, and Blood Institute (NHLBI) |
United States,
American Psychiatric Association. Diagnostic and Statistical Manual Of Mental Disorders (DSM-5®). American Psychiatric Pub; 2013.
Angerer P, Schmook R, Elfantel I, Li J. Night Work and the Risk of Depression. Dtsch Arztebl Int. 2017 Jul 16;114(24):404-411. doi: 10.3238/arztebl.2017.0404. — View Citation
Arendt J. Shift work: coping with the biological clock. Occup Med (Lond). 2010 Jan;60(1):10-20. doi: 10.1093/occmed/kqp162. — View Citation
Barger LK, Lockley SW, Rajaratnam SM, Landrigan CP. Neurobehavioral, health, and safety consequences associated with shift work in safety-sensitive professions. Curr Neurol Neurosci Rep. 2009 Mar;9(2):155-64. doi: 10.1007/s11910-009-0024-7. — View Citation
Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4. — View Citation
Bei B, Wiley JF, Trinder J, Manber R. Beyond the mean: A systematic review on the correlates of daily intraindividual variability of sleep/wake patterns. Sleep Med Rev. 2016 Aug;28:108-24. doi: 10.1016/j.smrv.2015.06.003. Epub 2015 Jul 2. — View Citation
Bellg AJ, Borrelli B, Resnick B, Hecht J, Minicucci DS, Ory M, Ogedegbe G, Orwig D, Ernst D, Czajkowski S; Treatment Fidelity Workgroup of the NIH Behavior Change Consortium. Enhancing treatment fidelity in health behavior change studies: best practices and recommendations from the NIH Behavior Change Consortium. Health Psychol. 2004 Sep;23(5):443-51. doi: 10.1037/0278-6133.23.5.443. — View Citation
Boivin DB, James FO. Circadian adaptation to night-shift work by judicious light and darkness exposure. J Biol Rhythms. 2002 Dec;17(6):556-67. doi: 10.1177/0748730402238238. — View Citation
Bonnefond A, Muzet A, Winter-Dill AS, Bailloeuil C, Bitouze F, Bonneau A. Innovative working schedule: introducing one short nap during the night shift. Ergonomics. 2001 Aug 15;44(10):937-45. doi: 10.1080/00140130110061138. — View Citation
Brown DL, Feskanich D, Sanchez BN, Rexrode KM, Schernhammer ES, Lisabeth LD. Rotating night shift work and the risk of ischemic stroke. Am J Epidemiol. 2009 Jun 1;169(11):1370-7. doi: 10.1093/aje/kwp056. Epub 2009 Apr 8. — View Citation
Bureau of Labor Statistics UDoL. Occupational Outlook Handbook, Registered Nurses. 2020.
Bureau of Labor Statistics. Standard occupational classification groups. 2018. Retrieved from bls.gov/soc/
Carney CE, Buysse DJ, Ancoli-Israel S, Edinger JD, Krystal AD, Lichstein KL, Morin CM. The consensus sleep diary: standardizing prospective sleep self-monitoring. Sleep. 2012 Feb 1;35(2):287-302. doi: 10.5665/sleep.1642. — View Citation
Carney CE, Edinger JD, Kuchibhatla M, Lachowski AM, Bogouslavsky O, Krystal AD, Shapiro CM. Cognitive Behavioral Insomnia Therapy for Those With Insomnia and Depression: A Randomized Controlled Clinical Trial. Sleep. 2017 Apr 1;40(4):zsx019. doi: 10.1093/sleep/zsx019. — View Citation
Carter PA, Dyer KA, Mikan SQ. Sleep disturbance, chronic stress, and depression in hospice nurses: testing the feasibility of an intervention. Oncol Nurs Forum. 2013 Sep;40(5):E368-73. doi: 10.1188/13.ONF.E368-E373. — View Citation
Chung F, Abdullah HR, Liao P. STOP-Bang Questionnaire: A Practical Approach to Screen for Obstructive Sleep Apnea. Chest. 2016 Mar;149(3):631-8. doi: 10.1378/chest.15-0903. Epub 2016 Jan 12. — View Citation
Chung F, Yegneswaran B, Liao P, Chung SA, Vairavanathan S, Islam S, Khajehdehi A, Shapiro CM. STOP questionnaire: a tool to screen patients for obstructive sleep apnea. Anesthesiology. 2008 May;108(5):812-21. doi: 10.1097/ALN.0b013e31816d83e4. — View Citation
Crowley SJ, Lee C, Tseng CY, Fogg LF, Eastman CI. Combinations of bright light, scheduled dark, sunglasses, and melatonin to facilitate circadian entrainment to night shift work. J Biol Rhythms. 2003 Dec;18(6):513-23. doi: 10.1177/0748730403258422. — View Citation
Crowley SJ, Lee C, Tseng CY, Fogg LF, Eastman CI. Complete or partial circadian re-entrainment improves performance, alertness, and mood during night-shift work. Sleep. 2004 Sep 15;27(6):1077-87. doi: 10.1093/sleep/27.6.1077. — View Citation
Dietch J, Wu J, Slavish D, et al. Characteristics of participants in trials of cognitive-behavioral therapy for insomnia: a systematic review and data synthesis. Pre-registered at PROSPERO (ID: CRD42020159476). In preparation.
Drake CL, Roehrs T, Richardson G, Walsh JK, Roth T. Shift work sleep disorder: prevalence and consequences beyond that of symptomatic day workers. Sleep. 2004 Dec 15;27(8):1453-62. doi: 10.1093/sleep/27.8.1453. — View Citation
Fiorentino L, McQuaid JR, Liu L, Natarajan L, He F, Cornejo M, Lawton S, Parker BA, Sadler GR, Ancoli-Israel S. Individual cognitive behavioral therapy for insomnia in breast cancer survivors: a randomized controlled crossover pilot study. Nat Sci Sleep. 2010 Dec 16;2:1-8. doi: 10.2147/nss.s8004. Print 2010. — View Citation
Frost P, Kolstad HA, Bonde JP. Shift work and the risk of ischemic heart disease - a systematic review of the epidemiologic evidence. Scand J Work Environ Health. 2009 May;35(3):163-79. doi: 10.5271/sjweh.1319. Epub 2009 Apr 22. — View Citation
Gan Y, Yang C, Tong X, Sun H, Cong Y, Yin X, Li L, Cao S, Dong X, Gong Y, Shi O, Deng J, Bi H, Lu Z. Shift work and diabetes mellitus: a meta-analysis of observational studies. Occup Environ Med. 2015 Jan;72(1):72-8. doi: 10.1136/oemed-2014-102150. Epub 2014 Jul 16. — View Citation
Ganesan S, Magee M, Stone JE, Mulhall MD, Collins A, Howard ME, Lockley SW, Rajaratnam SMW, Sletten TL. The Impact of Shift Work on Sleep, Alertness and Performance in Healthcare Workers. Sci Rep. 2019 Mar 15;9(1):4635. doi: 10.1038/s41598-019-40914-x. — View Citation
Garbarino S, Mascialino B, Penco MA, Squarcia S, De Carli F, Nobili L, Beelke M, Cuomo G, Ferrillo F. Professional shift-work drivers who adopt prophylactic naps can reduce the risk of car accidents during night work. Sleep. 2004 Nov 1;27(7):1295-302. doi: 10.1093/sleep/27.7.1295. — View Citation
Geiger-Brown JM, Rogers VE, Liu W, Ludeman EM, Downton KD, Diaz-Abad M. Cognitive behavioral therapy in persons with comorbid insomnia: A meta-analysis. Sleep Med Rev. 2015 Oct;23:54-67. doi: 10.1016/j.smrv.2014.11.007. Epub 2014 Nov 29. — View Citation
Givens ML, Malecki KC, Peppard PE, Palta M, Said A, Engelman CD, Walsh MC, Nieto FJ. Shiftwork, Sleep Habits, and Metabolic Disparities: Results from the Survey of the Health of Wisconsin. Sleep Health. 2015 Jun;1(2):115-120. doi: 10.1016/j.sleh.2015.04.014. — View Citation
Gu F, Han J, Laden F, Pan A, Caporaso NE, Stampfer MJ, Kawachi I, Rexrode KM, Willett WC, Hankinson SE, Speizer FE, Schernhammer ES. Total and cause-specific mortality of U.S. nurses working rotating night shifts. Am J Prev Med. 2015 Mar;48(3):241-52. doi: 10.1016/j.amepre.2014.10.018. Epub 2015 Jan 6. — View Citation
Hallbeck MS, Lowndes BR, Bingener J, Abdelrahman AM, Yu D, Bartley A, Park AE. The impact of intraoperative microbreaks with exercises on surgeons: A multi-center cohort study. Appl Ergon. 2017 Apr;60:334-341. doi: 10.1016/j.apergo.2016.12.006. Epub 2016 Dec 29. — View Citation
Hansen J, Lassen CF. Nested case-control study of night shift work and breast cancer risk among women in the Danish military. Occup Environ Med. 2012 Aug;69(8):551-6. doi: 10.1136/oemed-2011-100240. Epub 2012 May 29. — View Citation
Harma M, Tenkanen L, Sjoblom T, Alikoski T, Heinsalmi P. Combined effects of shift work and life-style on the prevalence of insomnia, sleep deprivation and daytime sleepiness. Scand J Work Environ Health. 1998 Aug;24(4):300-7. doi: 10.5271/sjweh.324. — View Citation
Harvey AG, Soehner AM, Kaplan KA, Hein K, Lee J, Kanady J, Li D, Rabe-Hesketh S, Ketter TA, Neylan TC, Buysse DJ. Treating insomnia improves mood state, sleep, and functioning in bipolar disorder: a pilot randomized controlled trial. J Consult Clin Psychol. 2015 Jun;83(3):564-77. doi: 10.1037/a0038655. Epub 2015 Jan 26. — View Citation
Horowitz TS, Cade BE, Wolfe JM, Czeisler CA. Efficacy of bright light and sleep/darkness scheduling in alleviating circadian maladaptation to night work. Am J Physiol Endocrinol Metab. 2001 Aug;281(2):E384-91. doi: 10.1152/ajpendo.2001.281.2.E384. — View Citation
Huang LB, Tsai MC, Chen CY, Hsu SC. The effectiveness of light/dark exposure to treat insomnia in female nurses undertaking shift work during the evening/night shift. J Clin Sleep Med. 2013 Jul 15;9(7):641-6. doi: 10.5664/jcsm.2824. — View Citation
Jackson ML, Banks S, Belenky G. Investigation of the effectiveness of a split sleep schedule in sustaining sleep and maintaining performance. Chronobiol Int. 2014 Dec;31(10):1218-30. doi: 10.3109/07420528.2014.957305. Epub 2014 Sep 15. — View Citation
Jarnefelt H, Harma M, Sallinen M, Virkkala J, Paajanen T, Martimo KP, Hublin C. Cognitive behavioural therapy interventions for insomnia among shift workers: RCT in an occupational health setting. Int Arch Occup Environ Health. 2020 Jul;93(5):535-550. doi: 10.1007/s00420-019-01504-6. Epub 2019 Dec 18. Erratum In: Int Arch Occup Environ Health. 2020 Mar 3;: — View Citation
Jarnefelt H, Lagerstedt R, Kajaste S, Sallinen M, Savolainen A, Hublin C. Cognitive behavioral therapy for shift workers with chronic insomnia. Sleep Med. 2012 Dec;13(10):1238-46. doi: 10.1016/j.sleep.2012.10.003. Epub 2012 Nov 16. — View Citation
Jia Y, Lu Y, Wu K, Lin Q, Shen W, Zhu M, Huang S, Chen J. Does night work increase the risk of breast cancer? A systematic review and meta-analysis of epidemiological studies. Cancer Epidemiol. 2013 Jun;37(3):197-206. doi: 10.1016/j.canep.2013.01.005. Epub 2013 Feb 9. — View Citation
Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991 Dec;14(6):540-5. doi: 10.1093/sleep/14.6.540. — View Citation
Johnson AL, Jung L, Song Y, Brown KC, Weaver MT, Richards KC. Sleep deprivation and error in nurses who work the night shift. J Nurs Adm. 2014 Jan;44(1):17-22. doi: 10.1097/NNA.0000000000000016. Erratum In: J Nurs Adm. 2014 Mar;44(3):186. Song, Yeonsu [added]. — View Citation
Karhula K, Hakola T, Koskinen A, Ojajarvi A, Kivimaki M, Harma M. Permanent night workers sleep and psychosocial factors in hospital work. A comparison to day and shift work. Chronobiol Int. 2018 Jun;35(6):785-794. doi: 10.1080/07420528.2018.1466792. Epub 2018 May 15. — View Citation
Karlsson B, Knutsson A, Lindahl B. Is there an association between shift work and having a metabolic syndrome? Results from a population based study of 27,485 people. Occup Environ Med. 2001 Nov;58(11):747-52. doi: 10.1136/oem.58.11.747. — View Citation
Ker K, Edwards PJ, Felix LM, Blackhall K, Roberts I. Caffeine for the prevention of injuries and errors in shift workers. Cochrane Database Syst Rev. 2010 May 12;2010(5):CD008508. doi: 10.1002/14651858.CD008508. — View Citation
Koffel EA, Koffel JB, Gehrman PR. A meta-analysis of group cognitive behavioral therapy for insomnia. Sleep Med Rev. 2015 Feb;19:6-16. doi: 10.1016/j.smrv.2014.05.001. Epub 2014 May 14. — View Citation
Krupp LB, LaRocca NG, Muir-Nash J, Steinberg AD. The fatigue severity scale. Application to patients with multiple sclerosis and systemic lupus erythematosus. Arch Neurol. 1989 Oct;46(10):1121-3. doi: 10.1001/archneur.1989.00520460115022. — View Citation
Lajoie P, Aronson KJ, Day A, Tranmer J. A cross-sectional study of shift work, sleep quality and cardiometabolic risk in female hospital employees. BMJ Open. 2015 Mar 10;5(3):e007327. doi: 10.1136/bmjopen-2014-007327. — View Citation
Lee A, Myung SK, Cho JJ, Jung YJ, Yoon JL, Kim MY. Night Shift Work and Risk of Depression: Meta-analysis of Observational Studies. J Korean Med Sci. 2017 Jul;32(7):1091-1096. doi: 10.3346/jkms.2017.32.7.1091. — View Citation
Lee KA. Self-reported sleep disturbances in employed women. Sleep. 1992 Dec;15(6):493-8. doi: 10.1093/sleep/15.6.493. — View Citation
Leon AC, Davis LL, Kraemer HC. The role and interpretation of pilot studies in clinical research. J Psychiatr Res. 2011 May;45(5):626-9. doi: 10.1016/j.jpsychires.2010.10.008. Epub 2010 Oct 28. — View Citation
Lin X, Chen W, Wei F, Ying M, Wei W, Xie X. Night-shift work increases morbidity of breast cancer and all-cause mortality: a meta-analysis of 16 prospective cohort studies. Sleep Med. 2015 Nov;16(11):1381-1387. doi: 10.1016/j.sleep.2015.02.543. Epub 2015 May 11. — View Citation
Manber R, Bernert RA, Suh S, Nowakowski S, Siebern AT, Ong JC. CBT for insomnia in patients with high and low depressive symptom severity: adherence and clinical outcomes. J Clin Sleep Med. 2011 Dec 15;7(6):645-52. doi: 10.5664/jcsm.1472. — View Citation
Manber R, Carney CE. Treatment plans and interventions for insomnia: a case formulation approach. Guilford Publications; 2015.
McMenamin TM. A time to work: recent trends in shift work and flexible schedules. Monthly Lab Rev. 2007;130:3.
Minors DS, Waterhouse JM. Does 'anchor sleep' entrain circadian rhythms? Evidence from constant routine studies. J Physiol. 1983 Dec;345:451-67. doi: 10.1113/jphysiol.1983.sp014988. — View Citation
Moore CG, Carter RE, Nietert PJ, Stewart PW. Recommendations for planning pilot studies in clinical and translational research. Clin Transl Sci. 2011 Oct;4(5):332-7. doi: 10.1111/j.1752-8062.2011.00347.x. — View Citation
Morgenthaler TI, Lee-Chiong T, Alessi C, Friedman L, Aurora RN, Boehlecke B, Brown T, Chesson AL Jr, Kapur V, Maganti R, Owens J, Pancer J, Swick TJ, Zak R; Standards of Practice Committee of the American Academy of Sleep Medicine. Practice parameters for the clinical evaluation and treatment of circadian rhythm sleep disorders. An American Academy of Sleep Medicine report. Sleep. 2007 Nov;30(11):1445-59. doi: 10.1093/sleep/30.11.1445. Erratum In: Sleep. 2008 Jul 1;31(7):table of contents. — View Citation
Morin CM, Belleville G, Belanger L, Ivers H. The Insomnia Severity Index: psychometric indicators to detect insomnia cases and evaluate treatment response. Sleep. 2011 May 1;34(5):601-8. doi: 10.1093/sleep/34.5.601. — View Citation
Morin CM, Culbert JP, Schwartz SM. Nonpharmacological interventions for insomnia: a meta-analysis of treatment efficacy. Am J Psychiatry. 1994 Aug;151(8):1172-80. doi: 10.1176/ajp.151.8.1172. — View Citation
Murtagh DR, Greenwood KM. Identifying effective psychological treatments for insomnia: a meta-analysis. J Consult Clin Psychol. 1995 Feb;63(1):79-89. doi: 10.1037//0022-006x.63.1.79. — View Citation
Okajima I, Komada Y, Inoue Y. A meta-analysis on the treatment effectiveness of cognitive behavioral therapy for primary insomnia. Sleep Biol Rhythms. 2011;9(1):24-34.
Oyane NM, Pallesen S, Moen BE, Akerstedt T, Bjorvatn B. Associations between night work and anxiety, depression, insomnia, sleepiness and fatigue in a sample of Norwegian nurses. PLoS One. 2013 Aug 7;8(8):e70228. doi: 10.1371/journal.pone.0070228. eCollection 2013. — View Citation
Peter L, Reindl R, Zauter S, Hillemacher T, Richter K. Effectiveness of an Online CBT-I Intervention and a Face-to-Face Treatment for Shift Work Sleep Disorder: A Comparison of Sleep Diary Data. Int J Environ Res Public Health. 2019 Aug 24;16(17):3081. doi: 10.3390/ijerph16173081. — View Citation
Pruiksma KE, Taylor DJ, Mintz J, Nicholson KL, Rodgers M, Young-McCaughan S, Hall-Clark BN, Fina BA, Dondanville KA, Cobos B, Wardle-Pinkston S, Litz BT, Roache JD, Peterson AL; STRONG STAR Consortium. A pilot randomized controlled trial of cognitive behavioral treatment for trauma-related nightmares in active duty military personnel. J Clin Sleep Med. 2020 Jan 15;16(1):29-40. doi: 10.5664/jcsm.8116. Epub 2019 Nov 26. — View Citation
Rao D, Yu H, Bai Y, Zheng X, Xie L. Does night-shift work increase the risk of prostate cancer? a systematic review and meta-analysis. Onco Targets Ther. 2015 Oct 5;8:2817-26. doi: 10.2147/OTT.S89769. eCollection 2015. — View Citation
Schweitzer PK, Randazzo AC, Stone K, Erman M, Walsh JK. Laboratory and field studies of naps and caffeine as practical countermeasures for sleep-wake problems associated with night work. Sleep. 2006 Jan;29(1):39-50. doi: 10.1093/sleep/29.1.39. — View Citation
Seligman ME. The effectiveness of psychotherapy. The Consumer Reports study. Am Psychol. 1995 Dec;50(12):965-74. doi: 10.1037//0003-066x.50.12.965. — View Citation
Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, Hergueta T, Baker R, Dunbar GC. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59 Suppl 20:22-33;quiz 34-57. — View Citation
Sim J, Lewis M. The size of a pilot study for a clinical trial should be calculated in relation to considerations of precision and efficiency. J Clin Epidemiol. 2012 Mar;65(3):301-8. doi: 10.1016/j.jclinepi.2011.07.011. Epub 2011 Dec 9. — View Citation
Smith MR, Fogg LF, Eastman CI. A compromise circadian phase position for permanent night work improves mood, fatigue, and performance. Sleep. 2009 Nov;32(11):1481-9. doi: 10.1093/sleep/32.11.1481. — View Citation
Smith MT, Huang MI, Manber R. Cognitive behavior therapy for chronic insomnia occurring within the context of medical and psychiatric disorders. Clin Psychol Rev. 2005 Jul;25(5):559-92. doi: 10.1016/j.cpr.2005.04.004. — View Citation
Spielman AJ, Saskin P, Thorpy MJ. Treatment of chronic insomnia by restriction of time in bed. Sleep. 1987 Feb;10(1):45-56. — View Citation
Stepanski EJ, Perlis ML. Behavioral sleep medicine. An emerging subspecialty in health psychology and sleep medicine. J Psychosom Res. 2000 Nov;49(5):343-7. doi: 10.1016/s0022-3999(00)00171-9. — View Citation
Tang NK, Goodchild CE, Salkovskis PM. Hybrid cognitive-behaviour therapy for individuals with insomnia and chronic pain: a pilot randomised controlled trial. Behav Res Ther. 2012 Dec;50(12):814-21. doi: 10.1016/j.brat.2012.08.006. Epub 2012 Sep 10. — View Citation
Taylor DJ, Pruiksma KE. Cognitive and behavioural therapy for insomnia (CBT-I) in psychiatric populations: a systematic review. Int Rev Psychiatry. 2014 Apr;26(2):205-13. doi: 10.3109/09540261.2014.902808. — View Citation
Taylor DJ, Wilkerson AK, Pruiksma KE, Dietch JR, Wardle-Pinkston S. Structured Clinical interview for Sleep Disorders-Revised (SCISD-R). 2019. Retrieved from insomnia.arizona.edu/scisd
Taylor DJ, Wilkerson AK, Pruiksma KE, Williams JM, Ruggero CJ, Hale W, Mintz J, Organek KM, Nicholson KL, Litz BT, Young-McCaughan S, Dondanville KA, Borah EV, Brundige A, Peterson AL; STRONG STAR Consortium. Reliability of the Structured Clinical Interview for DSM-5 Sleep Disorders Module. J Clin Sleep Med. 2018 Mar 15;14(3):459-464. doi: 10.5664/jcsm.7000. — View Citation
Taylor DJ, Zimmerman MR, Gardner CE, Williams JM, Grieser EA, Tatum JI, Bramoweth AD, Francetich JM, Ruggero C. A pilot randomized controlled trial of the effects of cognitive-behavioral therapy for insomnia on sleep and daytime functioning in college students. Behav Ther. 2014 May;45(3):376-89. doi: 10.1016/j.beth.2013.12.010. Epub 2014 Jan 3. — View Citation
Torquati L, Mielke GI, Brown WJ, Kolbe-Alexander T. Shift work and the risk of cardiovascular disease. A systematic review and meta-analysis including dose-response relationship. Scand J Work Environ Health. 2018 May 1;44(3):229-238. doi: 10.5271/sjweh.3700. Epub 2017 Dec 16. — View Citation
Tremaine R, Dorrian J, Lack L, Lovato N, Ferguson S, Zhou X, Roach G. The relationship between subjective and objective sleepiness and performance during a simulated night-shift with a nap countermeasure. Appl Ergon. 2010 Dec;42(1):52-61. doi: 10.1016/j.apergo.2010.04.005. Epub 2010 May 14. — View Citation
Vallières A, Bastille-Denis E, Morin C, Espie C. Circadian rhythm disorders II-shift work. The Oxford Handbook of Sleep and Sleep Disorders. 2012;1:626-643.
Vallières A, Roy M, Bastille-Denis E, Claveau S, Simon T. Exploring a behavioural therapy for insomnia in shift workers. J Sleep Disord Ther. 2015;4(202);2167-0277.
Van Dongen HP, Price NJ, Mullington JM, Szuba MP, Kapoor SC, Dinges DF. Caffeine eliminates psychomotor vigilance deficits from sleep inertia. Sleep. 2001 Nov 1;24(7):813-9. doi: 10.1093/sleep/24.7.813. — View Citation
Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3. — View Citation
Zee PC, Goldstein CA. Treatment of shift work disorder and jet lag. Curr Treat Options Neurol. 2010 Sep;12(5):396-411. doi: 10.1007/s11940-010-0090-9. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Retention Rate | Defined as [number of participants who complete minimal therapeutic dose (at least 4 sessions)] / [number of randomized participants in treatment arm] | At the post-treatment assessment (occurring at approximately 10 weeks) | |
Primary | Session Attendance | For enrolled participants, attendance rates will be calculated as [number of visits attended] / [number of total visits] | At the post-treatment assessment (occurring at approximately 10 weeks) | |
Primary | Implementation Assessment Measure | Validated questionnaire; total score range between 12 and 60, with higher numbers representing greater feasibility, acceptability, and appropriateness. | At the post-treatment assessment (occurring at approximately 10 weeks) | |
Secondary | Patient Adherence | be assessed by examining light exposure (from actigraphy), sleep timing relative to recommendations (sleep diary, actigraphy), and self-rated adherence to recommendations (items added to standard sleep diary) | At the post-treatment assessment (occurring at approximately 10 weeks) | |
Secondary | Therapist Fidelity | Therapist fidelity to the intervention components will be assessed with a treatment component checklist which is derived specifically for SWISH. This instrument consists of items corresponding to therapist verbal instruction or action that should occur for a given intervention component. The % of completed items will be computed for each session. | At the post-treatment assessment (occurring at approximately 10 weeks) | |
Secondary | Acceptability of Study Procedures and SWISH | Enrollment %, number of study assessment visits completed, and therapist-rated usability of treatment materials will be calculated and summarized. | After treatment is completed (occurring at approximately 10 weeks) | |
Secondary | Mean 24-hour sleep duration and efficiency | Mean 24-hour subjective sleep duration and efficiency will be assessed using the Consensus Sleep Diary and actigraphy. Sleep diary is a daily, prospective self-report measure that provides subjective estimates of sleep parameters. Actigraphy is a wrist-worn, wristwatch-like devices that assesses movement as a proxy for sleep and wake patterning. | At baseline and the post-treatment assessment (occurring at approximately 10 weeks) | |
Secondary | Change in Fatigue Severity Scale | Validated questionnaire; total score range between 9 and 63, with higher numbers representing greater fatigue | At baseline and the post-treatment assessment (occurring at approximately 10 weeks) | |
Secondary | Change in Epworth Sleepiness Scale | The Epworth Sleepiness Scale is a validated 8-item self-report measure used to assess sleepiness during waking hours, with higher numbers representing greater sleepiness. | At baseline and the post-treatment assessment (occurring at approximately 10 weeks) | |
Secondary | Executive functioning | assessed with the Joggle Research Battery, a brief iPad interactive cognitive testing battery which tracks cognitive functioning domains using a series of eight tasks. Executive functioning domains of interest are directly relevant to work performance and include risk decision making, vigilant attention, working memory, and visual learning. | At baseline and the post-treatment assessment (occurring at approximately 10 weeks) | |
Secondary | PROMIS Sleep Related Impairment | A validated 8-item Common Data Element measures which assess sleep health broadly as manifested during wake. Validated questionnaire; total score range between 8-40, with higher numbers indicating greater sleep-related wake time impairment | At baseline and at the post-treatment assessment (occurring at approximately 10 weeks) | |
Secondary | PROMIS Sleep Disturbances | A validated 8-item Common Data Element measures which assess sleep health broadly as manifested during sleep. Validated questionnaire; total score range between 8-40, with higher numbers indicating greater sleep disturbances. | At baseline and at the post-treatment assessment (occurring at approximately 10 weeks) |
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